About
Mastering Clinical Study Protocols: Practical Skills for Clinical Study Design
The clinical study protocol is the essential reference document for any research project. It defines a study's objectives, methodology, responsibilities, timelines, and overall organization, ensuring scientific integrity and regulatory compliance.
This hands-on workshop provides participants with the knowledge and tools to design, evaluate, and write high-quality clinical study protocols. Through interactive sessions, real examples, and group exercises, attendees will strengthen their understanding of protocol structure and content while gaining practical insight into achieving accuracy, completeness, and ethical robustness.
Learning Objectives
By the end of the training, participants will be able to:
- Identify and understand the key components of a clinical study protocol
- Apply current guidelines and templates to ensure accuracy and compliance
- Recognize the multidisciplinary roles involved in protocol development
- Assess the quality and feasibility of a protocol
- Avoid common errors and inconsistencies in study design and documentation
Programme
- The basics of protocol writing: Regulatory and legal needs
- Guidelines and templates
- Workshop: The use of AI: resource or trouble?
- Study design and methods
- Evaluation of the outcomes
- Auditing
- Ethical aspects
- Transparency and data publication
- Possible study development
- Conflicts of interest
- Authorship and administrative responsibilities
- Sample collection and management
- Workshop: Who has the information?
The workshop is aimed at all personnel working in structures involved in the development, review or management of a clinical study protocol, including Project Managers, Clinical Study Managers, Clinical Research Associates / Consultants, Medical Liaisons, Medical Directors, Pharmacovigilance, Legal, Medical Managers, Medical Writers, Regulatory, Data Managers, Statisticians of pharmaceutical companies, of devices or diagnostics producers, CROs and also to the staff of hospital/university or private research centres who need to write or participate in the creation of clinical study protocols.
Participant experience
Basic knowledge of clinical trial design and management.
Workshop.
Lecturers
Andrea Rossi
Andrea has more than 35 years of experience in clinical research and physician relations. He has authored more than 400 publications, including over 70 peer-reviewed papers. A former President of the European Medical Writers Association (EMWA), Andrea has led numerous training initiatives, workshops, and conferences on medical writing, scientific communication, and research on artificial intelligence.
He regularly collaborates with pharmaceutical, biotech, and medical device companies, universities, medical schools, research centers, and scientific societies across Europe.
This online training is divided in 3 modules:
Module 1 | 18 May 2026 from 02:00 pm to 05:30 pm CEST
Module 2 | 20 May 2026 from 02:00 pm to 05:30 pm CEST
Module 3 | 25 May 2026 from 02:00 pm to 05:30 pm CEST
The course admits maximum 12 attendees.
Some days before the online training you will receive all details about the connection.
The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
Early Bird: € 960,00* (until 27 April 2026)
Ordinary: € 1.170,00*
Freelance – Individual – Academy – Public Administration: € 670,00*
*for Italian companies: +22% VAT
The fee includes: tuition, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.
Register
Barbara Rossi
Training & Quality Manager
At the end of the training, you will be able to
Online interactive training on Zoom platform.
LS Academy will provide the access link to the virtual platform a few days before the training.